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FORZINITY

NDA · New Drug Application · Sponsor: STEALTH BIOTHERAPS · Approved 2025-09-19

Drug application

FDA Application #

NDA215244

Application type

New Drug Application

Brand name

FORZINITY

Generic name

ELAMIPRETIDE HYDROCHLORIDE

Active ingredients

ELAMIPRETIDE HYDROCHLORIDE

Dosage form

SOLUTION

Route

SUBCUTANEOUS

Marketing status

Prescription

Sponsor

STEALTH BIOTHERAPS

Manufacturer

Stealth Biotherapeutics Inc.

First approval

2025-09-19

Source

Authoritative

Drugs@FDA application overview

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